SAN DIEGO--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today reported on the continued advancement of its two Phase 1 trials for AB-SA01 and announced that it will host a conference call to report financial results for the second quarter ended June 30, 2016 on Monday, August 15, 2016 at 4:30 p.m. EDT. Highlights from the ongoing clinical trials of AB-SA01 include:
- Completed enrollment of the Phase 1 intact skin safety study with the US Army. Top-line results are expected to be released by the end of the third quarter of 2016. The complete study report is anticipated to be available later this year
- Initiated dosing of the first patient in the third and final cohort of the Australian Phase 1 trial in patients with chronic rhinosinusitis. AmpliPhi expects to share top-line results and the complete study report later this year
“We remain on schedule with both of our clinical trials for AB-SA01 and are poised to complete both studies and report top-line results later this year,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “Along with our clinical progress, we also brought in additional capital and received grants of key patents covering the use of phage therapy to resensitize drug-resistant bacteria to existing antibiotics. We are feverishly working to advance all of our programs with the goal of delivering an important new – and fundamentally different -- antibacterial modality to patients and caregivers.”
AmpliPhi initiated a Phase 1 clinical trial in January 2016 to treat Staphylococcus aureus (S. aureus) infections in patients suffering from chronic rhinosinusitis with AmpliPhi’s drug candidate AB-SA01. The study design calls for nine patients divided equally into three cohorts to be dosed at increasing durations and potency. AmpliPhi then initiated a second Phase 1 clinical trial in May 2016 under a U.S. IND. The double-blinded, placebo-controlled study was designed to evaluate the safety of AB-SA01 administered topically to the intact skin of 12 healthy adult volunteers. Clinical trial material for each study was produced at AmpliPhi’s cGMP facility in Ljubljana, Slovenia. AmpliPhi received cGMP approval in June 2015 and has produced material for two separate clinical trials and is currently manufacturing the AB-PA01 cocktail, expected to be used in 2017 for a Phase 1 trial in cystic fibrosis patients with Pseudomonas aeruginosa infections. The manufacturing facility allows AmpliPhi to maintain all manufacturing know-how and precisely control and monitor the manufacturing process to ensure patients receive top-quality drug.
AmpliPhi management will provide a detailed corporate update during the conference call on August 15th.
To access the call, dial 888-727-7690 (US) or 913-312-0978 (outside of the US). The passcode is 9616475. A live webcast will be available in the Events and Presentations section of the Investor Relations page at http://investor.ampliphibio.com/events-and-presentations. Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast of the call will be available in the Events and Presentations section of the company's website for 30 days.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (NYSEMKT: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and another Phase 1 clinical trial to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data for both trials in the second half of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa and Clostridium difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the expected timing of reporting data from AmpliPhi’s two AB-SA01 trials, the expected timing for initiating additional clinical trials, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.